1. Field of the Invention
The present invention relates generally to the field of medicine and, more particularly, to a balloon tamponade device and methods for controlling hemorrhage in a body cavity.
2. Related Art
The pelvis is the bony structure located at the base of the spine. Each hipbone (os coxae) consists of three bones: the illium, ischium, and the pubis. The two hipbones are joined anteriorly at the symphysis pubis and posteriorly to the sacrum. The pelvis incorporates the socket portion of the hip joint for each leg and forms the lower limb girdle of the skeleton. The pelvic cavity is a body cavity that is bounded by the bones of the pelvis and which primarily contains the reproductive organs, the urinary bladder, the appendix, part of the large intestine and the rectum. The abdominal cavity contains the stomach, spleen, liver, gall bladder, pancreas, small intestine and part of the large intestine. The abdominal cavity is not physically separated from the pelvic cavity, and frequently the cavities are referred to collectively as the abdominopelvic cavity.
Loss of blood internally into the abdominopelvic cavity occurs frequently with blunt trauma, blast injuries, pelvic fractures and abdominal or pelvic surgeries (e.g. hysterectomy), that cause injury to the network of blood vessels lying on the inner wall of the abdominal cavity and/or pelvic cavity. Up to 52% of patients with pelvic fractures will develop hemorrhagic shock in the emergency department. The management of abdominal and pelvic hemorrhage has been limited to more rigorous interventions, including pharmaceutical (e.g., recombinant Factor VIIa), surgical (e.g., vascular ligation, such as hypogastric artery ligation) and radiological (e.g., selective arterial embolization). Packing of the pelvic cavity (e.g., Logothetopulos, mushroom or umbrella pack) has been used to control pelvic hemorrhage, but there is not commercially available product. Pelvic packing is performed by the physician in situ using a sterile bag (e.g., a trash bag, X-ray cassette drape, etc) that is packed with gauze or other packing material that may later be removed from the bag. See, Dildly et al., An Effective Pressure Pack for Severe Pelvic Hemorrhage, Obstet. & Gynecol. 108(5):1222-1226 (2006). However, pelvic packing is difficult to insert, may not provide pressure where most needed (at the specific site of bleed or near involved vasculature), and may mask continued bleeding, making it difficult to determine whether hemorrhage has been effectively managed by the pelvic pack.
Significant blood loss may also occur in gynecologic and obstetric patients, for example due to trauma, abortion procedures, vaginal or cesarean delivery (e.g., lacerations to uterus, vagina or broad ligament or retained placental tissue), or due to a variety of other causes, including, placental abruption, placenta previa, placenta accreta or placenta percret or placenta increta, uterine atony, uterine inversion, coagulation disorders, chronic enodmetritis and placental polyps. Treatments to manage gynecologic/obstetric hemorrhage include: blood product (e.g., blood or platelet transfusion) and/or pharmaceutical intervention (e.g., Factor VIIa or other clotting mediators, and uterotonics, such as oxytocin, prostaglandins, misoprostol, methylergonovine, carboprost tromethamine, dinoprostone), uterine massage and compression sutures, surgical procedures (e.g., vascular ligation of the iliac, hypogastric, uterine and/or ovarian arteries), and interventional radiology procedures (e.g., selective arterial embolization). Hysterectomy is the measure of last recourse, particularly if the patient is of low parity.
Uterine and vaginal packing, similar to pelvic packing, have been used to treat uterine and vaginal hemorrhage, but packing for gynecologic/obstetric hemorrhage has largely been replaced by use of balloon catheters that were originally developed for other purposes, such as Foley catheters, Rusch catheters and Sengstaken-Blakemore tubes. See, Bowen L W and Beeson, J H, Use of a Large Foley Catheter Balloon to Control Postpartum Hemorrhage Resulting from a Low Placental Implantation, J. Reprod. Med. 30:623-628 (1985); Condous, G S et al., The Tamponade Test in the Management of Massive Postpartum Hemorrhage, Obstet. and Gynecol. 1201 (4):767-772 (2003). The SOS Bakri Tamponade Balloon Catheter (manufactured by Cook Medical Inc., Bloomington, Ind.) is the only commercially available balloon catheter specifically developed for management of postpartum hemorrhage from an intact uterus. Bakri Y N, Uterine tamponade-drain for hemorrhage secondary to placenta revia-accreta, Int. J. Gynecol Obstet 27: 302-303 (1992), Bakri, Y N, Balloon device for control of obstetrical bleeding, Euro J. Obstet Gynecol. Reprod. Biol. 86:584 (1999); Bakri Y N, et al., Tamponade-balloon for obstetrical bleeding, Int. J. Gynecol. Obstet. 74: 139-142 (2001). Balloon tamponade devices to manage vaginal and uterine hemorrhage are disclosed in U.S. Pat. Nos. 4,552,557; 5,062,425; 5,571,153; 5,674,239; 6,024,753; 6,520,977; 6,676,680; 7,220,252; and U.S. Patent Application Pub. Nos. 2006/0173486, 2005/0049627, and 2004/0030352.
However, there are disadvantages in existing balloon catheters used for uterine or vaginal hemorrhage. Existing balloon catheters are of a small volume (maximum full of 500 milliliters or less), and cannot be rapidly filled (inflated with a fluid) because the elasticity of the balloon creates a counter-inflation pressure that must first be overcome. For example, it takes significant applied pressure to inflate a Bakri device, delaying full inflation time (the inflation necessary to exert compression) for three-minutes or more. Also, when these balloon catheter devices are used to control uterine hemorrhage, external traction is applied to the lower portion of the balloon device so that it properly sits at the base of the lower uterine segment. Traction to the balloon tamponade requires a means to prevent the balloon catheter from being pulled downward into the vagina. Typically, the vagina is separately packed (even if not bleeding) to prevent the uterine balloon tamponade from being pulled by traction into the vagina, resulting in yet additional delay and preventing rapid control of uterine hemorrhage. Furthermore, frequently it is desirable to simultaneously control hemorrhage in the uterus and vagina, but there is no unitary device to provide tamponade to both such body cavities.
Due to the substantially larger volume of the abdominopelvic cavity, none of these existing vaginal or uterine balloon catheter devices is suitable for controlling hemorrhage in the pelvic or abdominal cavity. Thus, there is a need for an effective means to control hemorrhage from an abdominal or pelvic cavity. There is also a need to control hemorrhage from an abdominal or pelvic cavity that does not mask a continuing bleed. Further, there is a need for a device to control hemorrhage that provides separate lumens for administering fluids to the body cavity and for draining body fluids and debris from the body cavity. Further, there is a need for an apparatus having the ability to simultaneously control hemorrhage from a uterus and a vaginal body cavity. There is also a need for an effective means to rapidly control hemorrhage in a body cavity.
The present invention is directed to overcoming one or more of the problems set forth above. The inventions described herein are not limited in any manner by the descriptions or definitions, or the diagnostic or clinical indications or uses described herein.